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Business Wire Health: FDA News

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Last updated 39 minutes ago

Fasikl Receives FDA Clearance for Felix NeuroAI Wristband, the First and Only AI-Powered Treatment for Essential Tremor

39 minutes ago

MINNEAPOLIS--(BUSINESS WIRE)--Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic...

Median Technologies soumet un dossier pour le marquage CE classe II b d’eyonis® LCS, son logiciel dispositif médical basé sur l’Intelligence Artificielle pour le dépistage du cancer du poumon

about 6 hours ago

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, éligible PEA/PME, «...

Median Technologies Files European Application for Class IIb CE Marking of Its AI-Based Software as a Medical Device for Lung Cancer Screening, eyonis® LCS

about 6 hours ago

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible...

REPEAT/Cybin Announces Financing of up to US$500 Million Aggregate Principal Amount of Convertible Debentures

about 6 hours ago

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American: CYBN) (Cboe Canada: CYBN) (“Cybin” or the...

Merck KGaA, Darmstadt, Germany Completes Acquisition of SpringWorks Therapeutics to Accelerate Sustainable Growth of its Healthcare Business

about 9 hours ago

DARMSTADT, Germany--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, a leading science and technology company...

Fresenius Expands Biosimilars Portfolio With The Launch of Denosumab Biosimilars in the U.S.

about 10 hours ago

LAKE ZURICH, Ill.--(BUSINESS WIRE)-- #CommittedToLife--Fresenius announced today that its operating company Fresenius...

FELIQS announces $9 Million Series A Financing to Advance FLQ-101 Clinical Program for Retinopathy of Prematurity

about 10 hours ago

FUKUOKA, Japan & NEW YORK--(BUSINESS WIRE)--FELIQS Corporation (“FELIQS”), a biotechnology company developing...

Cybin Announces Financing of up to US$500 Million Aggregate Principal Amount of Convertible Debentures

about 20 hours ago

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American: CYBN) (Cboe Canada: CYBN) (“Cybin” or the...

Iksuda Therapeutics Receives FDA IND Clearance for IKS014

about 22 hours ago

NEWCASTLE, England--(BUSINESS WIRE)--Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates...

Sarepta Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

about 23 hours ago

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine...

Neurogene Announces Registrational Trial Design for Embolden™ Study of NGN-401 Gene Therapy for Rett Syndrome

1 day ago

NEW YORK--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring...

Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content1

1 day ago

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S...